BlueCross BlueShield of Tennessee Medical Policy Manual

Tocilizumab (Intravenous)

NDC CODE(S)

50242-0135-XX Actemra 80 MG/4ML SOLN (GENENTECH)

 

50242-0136-XX Actemra 200 MG/10ML SOLN (GENENTECH)

 

50242-0137-XX Actemra 400 MG/20ML SOLN (GENENTECH)

DESCRIPTION

Tocilizumab is a recombinant interleukin 6 (IL-6) receptor monoclonal antibody classified as a disease modifying antirheumatic drug.  It binds specifically to soluble and membrane-bound IL-6 receptors and has been shown to block IL-6-mediated signaling through these receptors.  IL-6 is a pro-inflammatory cytokine produced by a variety of cell types, including synovial and endothelial cells in joints affected by inflammatory processes.

POLICY

MEDICAL APPROPRIATENESS

INITIAL APPROVAL

RENEWAL CRITERIA

(Oncology Indications)

      • NHL - Castleman’s Disease - tumor response with stabilization of disease or decrease in size of tumor or tumor spread

(Non-Oncology Indications)

      • Rheumatoid arthritis (RA); Juvenile Idiopathic Arthritis (SJIA),(PJIA)

        • disease response as indicated by improvement in signs and compared to baseline such as the number of tender and swollen joint counts

      • Cytokine Release Syndrome

        • May not be renewed

*Doses exceeding 800 mg per infusion are not recommended

INDICATION(S)

DOSAGE & ADMINISTRATION

Adult Rheumatoid Arthritis

4 mg/kg  IV every 4 weeks

  • May increase to 8 mg/kg every 4 weeks based on clinical response

Polyarticular Juvenile Idiopathic Arthritis

Weight ≥ 30 kg

  • 8 mg/kg IV every 4 weeks

Weight < 30 kg

  • 10 mg/kg IV every 4 weeks

Systemic Juvenile Idiopathic Arthritis

Weight ≥ 30 kg

  • 8 mg/kg IV every 2 weeks

Weight < 30 kg

12 mg/kg IV every 2 weeks

Castleman’s Disease (NHL)

8 mg/kg IV every 2 weeks for 16 weeks (8 doses)

Cytokine Release Syndrome (CRS)

Weight ≥ 30 kg

·       8 mg/kg IV every 8 hours, if needed, up to a maximum of 4 total doses*

Weight < 30 kg

·       12 mg/kg IV every 8 hours, if needed, up to a maximum of 4 total doses*

*If no clinical improvement in the signs and symptoms of CRS occurs after the first dose, up to 3 additional doses may be administered. The interval between consecutive doses should be at least 8 hours. May be used with or without corticosteroids.

Length of Authorization

Click here to view DOSAGE LIMITS 

APPLICABLE TENNESSEE STATE MANDATE REQUIREMENTS

BlueCross BlueShield of Tennessee’s Medical Policy complies with Tennessee Code Annotated Section 56-7-2352 regarding coverage of off-label indications of Food and Drug Administration (FDA) approved drugs when the off-label use is recognized in one of the statutorily recognized standard reference compendia or in the published peer-reviewed medical literature.

IMPORTANT REMINDER

We develop Medical Policies to provide guidance to Members and Providers.  This Medical Policy relates only to the services or supplies described in it.  The existence of a Medical Policy is not an authorization, certification, explanation of benefits or a contract for the service (or supply) that is referenced in the Medical Policy.  For a determination of the benefits that a Member is entitled to receive under his or her health plan, the Member's health plan must be reviewed.  If there is a conflict between the Medical Policy and a health plan, the express terms of the health plan will govern.

ADDITIONAL INFORMATION 

For appropriate chemotherapy regimens, dosage information, contraindications, precautions, warnings, and monitoring information, please refer to one of the standard reference compendia (e.g., the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) published by the National Comprehensive Cancer Network®, Drugdex Evaluations of Micromedex Solutions at Truven Health, or The American Hospital Formulary Service Drug Information).

In a review of the published literature, no controlled studies were found to validate the use of tocilizumab in the treatment or prevention of any other condition or disease.

SOURCES

Lexi-Comp Online. (2017, March). AHFS DI. Tocilizumab. Retrieved November 15, 2017 from Lexi-Comp Online with AHFS.

MICROMEDEX Healthcare Series. Drugdex Evaluations. (2017, September). Tocilizumab. Retrieved November 15, 2017 from MICROMEDEX Healthcare Series.

National Comprehensive Cancer Network. (2017). NCCN Drugs & Biologics Compendium®. Tocilizumab. Retrieved November 15, 2017 from the National Comprehensive Cancer Network.

Ringold, S., Weiss P.F., Beukelman T., DeWitt, E.M., Ilowite, N.T., Kimura, Y., et al. (2013, October). 2013 update of the 2011 American College of Rheumatology recommendations for the treatment of juvenile idiopathic arthritis: recommendations for the medical therapy of children with systemic juvenile idiopathic arthritis and tuberculosis screening among children receiving biologic medications. Arthritis & Rheumatism 65(10), 2499-512. Retrieved June 1, 2017 from https://www.rheumatology.org/Portals/0/Files/2013%20Update%20of%20the%202011%20ACR%20Recommendations%20for%20the%20Treatment%20of%20Juvenile%20Idiopathic%20Arthritis.pdf.

U. S. Food and Drug Administration. (2017, August). Center for Drug Evaluation and Research. Actemra® (tocilizumab). Retrieved November 15, 2017 from https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/125472s024lbledt.pdf.

ORIGINAL EFFECTIVE DATE:  7/10/2010

MOST RECENT REVIEW DATE:  2/16/2018

ID_MRx

Policies included in the Medical Policy Manual are not intended to certify coverage availability. They are medical determinations about a particular technology, service, drug, etc. While a policy or technology may be medically necessary, it could be excluded in a member's benefit plan. Please check with the appropriate claims department to determine if the service in question is a covered service under a particular benefit plan. Use of the Medical Policy Manual is not intended to replace independent medical judgment for treatment of individuals. The content on this Web site is not intended to be a substitute for professional medical advice in any way. Always seek the advice of your physician or other qualified health care provider if you have questions regarding a medical condition or treatment.

This document has been classified as public information.

 

 

DOSAGE LIMITS

Maximum billable units per dose and over time by indication as a Medical Benefit

Diagnosis

Billable Units

Interval (days)

Rheumatoid Arthritis & Polyarticular Juvenile Idiopathic Arthritis

800

28

Systemic Juvenile Idiopathic Arthritis & Castleman’s Disease (NHL)

800

14

Cytokine Release Syndrome (CRS)

3200

1 course of therapy only